H. Suryapranata

Heparin-coated Palmaz-Schatz stents in human coronary arteries. Early outcome of the Benestent-II Pilot Study.

BACKGROUND The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs. METHODS AND RESULTS The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin-coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase I to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-I study (80%; relative risk, 0.68 [0.45 to 1.04]). CONCLUSIONS The implantation of stents coated with polyamine and end-point-attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis, and results in a favorable event-free survival after 6 months.

Limitation of infarct size and preservation of left ventricular function after primary coronary angioplasty compared with intravenous streptokinase in acute myocardial infarction.

BackgroundEarly and effective flow through the infarct-related vessel is probably of paramount importance for limitation of infarct size and preservation of left ventricular function in patients with acute myocardial infarction. Primary coronary angioplasty may offer advantages in these respects compared with thrombolytic therapy. The purpose of the present study was to assess the effects on estimated enzymatic infarct size and left ventricular function in patients with acute myocardial infarction randomly assigned to undergo primary angioplasty or to receive intravenous streptokinase. Methods and ResultsWe evaluated 301 patients with signs of acute myocardial infarction and without contraindications for thrombolysis who presented within 6 hours after onset of symptoms or between 6 and 24 hours if there was evidence of ongoing ischemia. One hundred fifty-two patients were randomly assigned to undergo primary angioplasty, and 149 patients were assigned to receive treatment with streptokinase (1.5 million U IV). Infarct size was estimated from enzyme release. Global left ventricular ejection fraction and regional wall motion, if possible in combination with exercise testing, were evaluated by radionuclide ventriculography before discharge. Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 through the infarct-related vessel within 120 minutes after admission was achieved in 92% of all patients assigned to receive primary angioplasty therapy. Myocardial infarct size was 23% smaller in the angioplasty group compared with patients assigned to receive streptokinase (1003±784 versus 1310±1198 U/L, P=.012). Global left ventricular ejection fraction (50±9% versus 45±11%, P<.001) and regional wall motion in the infarct-related zones (42±14% versus 34±13%, P<.001) were better in the angioplasty group, which could mainly be contributed to myocardial salvage in the infarct-related areas. The observed differences were more pronounced in patients with an anterior wall myocardial infarction, although patients with a nonanterior infarct location also showed a beneficial effect of primary coronary angioplasty on left ventricular function compared with streptokinase therapy. Furthermore, the observed differences appeared to be more pronounced in patients presenting relatively early (within 2 hours) after onset of symptoms. ConclusionsIn patients with acute myocardial infarction, primary angioplasty results in a smaller infarct size and a better preserved myocardial function compared with patients randomized to receive treatment with intravenous streptoki-nase. This is probably due to early and optimal blood flow through the infarct-related vessel, as can be accomplished in a very high percentage of patients undergoing primary coronary angioplasty.

Predictive value of reactive hyperemic response on reperfusion on recovery of regional myocardial function after coronary angioplasty in acute myocardial infarction.

BACKGROUND The objective of the study was to determine the coronary vasodilatory reserve in reperfused myocardium in patients with acute myocardial infarction and its relation to regional myocardial function. METHODS AND RESULTS The study population consisted of 22 patients with acute myocardial infarction who underwent successful coronary angioplasty. The vasodilatory reserve in the reperfused myocardium was assessed quantitatively using computer-assisted digital subtraction cine-angiography immediately after angioplasty and at follow-up angiography before hospital discharge. Myocardial contrast medium appearance time and density were determined before and after pharmacological hyperemia induced by an intracoronary injection of 12.5 mg papaverine. Global and regional left ventricular functions were determined from contrast angiography. After papaverine, the mean contrast medium appearance time decreased significantly from 3.5 +/- 0.7 to 2.7 +/- 0.7 cardiac cycles (P < .000005) immediately after successful coronary angioplasty and from 3.8 +/- 0.7 to 2.7 +/- 0.9 cardiac cycles (P < .000005) at angiography before hospital discharge. The mean contrast medium density increased significantly from 48.7 +/- 13.8 to 61.0 +/- 19.0 pixels (P < .003) and from 49.6 +/- 19.7 to 80.3 +/- 29.6 pixels (P < .000005), respectively. As a consequence, the calculated coronary flow reserve increased significantly from 1.8 +/- 0.7 to 2.6 +/- 1.0 (P < .0008). The global ejection fraction increased significantly from 52 +/- 12% to 58 +/- 14% (P < .03), primarily because of a significant improvement in the regional myocardial function of the infarct zone from 20.8 +/- 9.0% to 26.0 +/- 10.5% (P < .001). Coronary flow reserve correlated well with regional myocardial function both during the acute phase (R = .79, P < .002) and at follow-up angiography (R = .82, P < .000004). Interestingly, coronary flow reserve measurement on reperfusion, immediately after angioplasty, correlated significantly with regional myocardial function at follow-up angiography (R = .81, P < .00003). CONCLUSIONS The results indicate that there is a pharmacologically inducible vasodilatory reserve in reperfused ischemic myocardium after successful coronary angioplasty in patients with acute myocardial infarction and that this is increased at 10-day follow-up angiography. More important, the degree of reactive hyperemic response on reperfusion has a predictive value regarding the ultimate degree of recovery of regional myocardial function. Quantitative assessment of reperfusion may be useful in investigating the role of coronary reperfusion and salvage of myocardial function.

Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomised comparison in a large cohort of unselected patients

Objective: To evaluate the impact of routine stenting, compared with balloon angioplasty, in unselected patients presenting with ST segment elevation myocardial infarction (STEMI). Design: Randomised trial. Setting: Tertiary referral centre. Participants: All patients presenting with STEMI randomly assigned to stenting or balloon angioplasty. No exclusion criteria were applied. Main outcome measure: The primary end point was combined death or reinfarction at one year’s follow up. Results: 1683 consecutive patients with STEMI were randomly assigned before angiography to stenting (n  =  849) or balloon angioplasty (n  =  834). A total of 785 patients (92.5%) in the stent group and 763 patients (91.5%) in the balloon group actually underwent primary angioplasty. The groups were comparable in terms of postprocedural TIMI (thrombolysis in myocardial infarction) flow, myocardial blush grade, and distal embolisation. No difference was observed in clinical outcome at both intention to treat (14% v 12.5%, not significant) and actual treatment analyses (12.4% v 11.3%, not significant). Conclusions: Compared with balloon angioplasty, routine stenting does not seem to reduce death and reinfarction in a large cohort of unselected patients with STEMI.

Primary percutaneous coronary intervention versus thrombolytic treatment: long term follow up according to infarct location

Objectives: To study the clinical significance of infarct location during long term follow up in a trial comparing thrombolysis with primary angioplasty. Design: Retrospective longitudinal cohort analysis of prospectively entered data. Setting: Patients with acute ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). Patients: In the Zwolle trial 395 patients with acute STEMI were randomly assigned to intravenous streptokinase or PCI. Main outcome measures: Survival according to infarct location and treatment after 8 (2) years of follow up. Results: 105 patients died: 63 patients in the streptokinase group and 42 patients in the primary PCI group (relative risk (RR) 1.6, 95% confidence interval (CI) 1.0 to 2.6; p  =  0.03). In patients with non-anterior STEMI there was no difference in mortality between streptokinase and PCI treated patients (RR 1.1, 95% CI 0.6 to 2.1; p  =  0.68) but the streptokinase group had significantly more major adverse cardiac events (MACE) than the PCI group (RR 2.1, 95% CI 1.2 to 3.6). The number needed to treat to prevent one MACE was four. In patients with anterior STEMI, mortality was higher in the streptokinase group than in the PCI group (RR 2.7, 95% CI 1.4 to 5.5; p  =  0.004). The number needed to treat to prevent one death was five. Kaplan-Meier analysis confirmed the benefits of primary angioplasty in the first year and showed additional benefit of PCI compared with streptokinase between 1–8 years after the acute event. Conclusions: Patients with anterior STEMI have better long term survival when treated with PCI than with streptokinase. In patients alive one year after the acute event, PCI confers a significant additional survival benefit, probably due to better preserved residual left ventricular function.

Multicenter evaluation of the phosphorylcholine-coated biodivYsio stent in short de novo coronary lesions: The SOPHOS study

AIMS: The BiodivYsio™ stent (Biocompatibles Ltd, Farnham, UK) is coated with a phosphorylcholine (PC)-containin copolymer to confer biocompatibility. The SOPHOS (Study Of PHosphorylcholine coating On Stents) study was designed to assess the safety and efficacy of this novel coronary stent and by indirect comparison to indicate equivalence with other formal stent studies. METHODS AND RESULTS: Patients with angina and a single short ( r 12 mm) de novo lesion in a native coronary artery of S 2.75 mm diameter were included. A total of 425 patients were allocated in 24 centers. Clinical data were collected at one-, six- and nine-month follow-up. Angiography was performed before and after the stent implantation. In addition, in the first 200 patients (SOPHOS A) angiography was routinely performed at six months. The following 225 patients (SOPHOS B) were merely followed up clinically. The primary end-point of the study, the six-month MACE-rate (MACE = Major Adverse Cardiac Events) was 13.4% (two cardiac death; five Q-wave/nine non-Qwave myocardial infarctions (MI); nine CABG and 32 target lesion revascularization (TLR), which is similar to the calculated 15% MACE-rate in comparable reference studies. Secondary end-points included among others restenosis at six months in the SOPHOS A population. The target vessel diameter was 2.98 - 0.48 mm. Minimal lumen diameter pre/post procedure and at follow-up was 1.00 - 0.32, 2.69 - 0.37, 1.91 - 0.71mm, respectively. The binary restenosis rate ( S 50% diameter stenosis at follow-up) was 17.7%. CONCLUSION: The coronary BiodivYsio stent is safe and effective as a primary device for the treatment of native coronary artery lesions in patients with stable or unstable angina pectoris. Clinical and angiographic results are in the statistical range of equivalence with comparable studies with other current stents. (Int J Cardiovasc Intervent 2000; 3: 215-225)

Acute effects of intravenous nisoldipine on left ventricular function and coronary hemodynamics

The hemodynamic effects of nisoldipine were investigated in 16 patients with suspected coronary artery disease who underwent routine cardiac catheterization. Nisoldipine was given intravenously in a dose of 6 micrograms/kg over 3 minutes and measurements made before and after drug administration during spontaneous and matched atrial paced heart rate. During sinus rhythm, nisoldipine produced a significant increase in heart rate (19%, p less than 10(-5]. Left ventricular systolic pressure decreased 28% (p less than 10(-6) and left ventricular end-diastolic pressure did not change significantly (5%, difference not significant). Coronary sinus and great cardiac vein blood flow increased by 21% (p less than 0.02) and 25% (p less than 0.005), respectively, after nisoldipine administration. Simultaneously, mean aortic pressure decreased 33% (p less than 10(-6]; consequently, the global and regional coronary vascular resistances decreased by 50% (p less than 10(-4]. The decreases in global (-8%) and regional (-4%) myocardial oxygen consumption did not reach statistical significance. A 6% (not significant) increase in end-diastolic volume and an 11% (p less than 0.002) decrease in end-systolic volume resulted in an increase of 21% in stroke volume (p less than 10(-4] with a consistent increase in ejection fraction (+16%, p less than 10(-5]. Total systemic vascular resistance was reduced by 30% (p less than 0.0002). During spontaneous heart rate and matched atrial pacing, the time constant of isovolumic relaxation as assessed by a biexponential model, was significantly shortened.(ABSTRACT TRUNCATED AT 250 WORDS)

Long-term impact of multivessel disease on cause- specific mortality after ST-elevation myocardial infarction treated with reperfusion therapy

Objectives: To investigate the long-term impact of multivessel coronary artery disease (MVD) on cause-specific mortality in patients with ST elevation myocardial infarction (STEMI) treated with reperfusion therapy. Methods and results: Patients with STEMI (n  =  395) treated with primary angioplasty or thrombolysis in the setting of a randomised clinical trial were enrolled in the study. Follow up was 8 (2) years. For patients who died all available records were reviewed to assess the specific cause of death. MVD was present in 57% of patients. Patients with MVD were older and more of them had diabetes and previous myocardial infarction. Compared with the non-MVD group, residual left ventricular ejection fraction was lower (45.9% v 49.6%, p  =  0.001) and total mortality was higher in patients with MVD (32% v 19%, p  =  0.002). After adjustment for potential confounders this association was not significant (hazard ratio 1.4, 95% confidence interval (CI) 0.9 to 2.2). When the specific cause of death was considered, sudden death was comparable between patients with and without MVD (10% v 8%, p  =  0.49) but death caused by heart failure was significantly higher in patients with MVD (hazard ratio 7.4, 95% CI 1.7 to 32.2). Conclusion: Patients with STEMI and MVD have a higher long-term mortality than do patients with non-MVD. MVD is not an independent predictor of long-term total mortality or sudden death. However, MVD is a very strong and independent predictor of long-term death caused by heart failure.

Time course, predictors and clinical implications of stent thrombosis following primary angioplasty. Insights from the DESERT cooperation

Primary percutaneous coronary intervention (pPCI) has improved survival as compared to thrombolysis. Concerns still remain regarding the risk of stent thrombosis in the setting of STEMI, especially after drug-eluting stent (DES) implantation. Therefore, the aim of this study was to report on the timing of stent thrombosis (ST) with both DES and bare metal stents (BMS) and its prognostic significance in patients undergoing pPCI. The Drug-Eluting Stent in Primary Angioplasty (DESERT) cooperation is based on a pooled database including individual data of randomised trials that evaluate the long-term safety and effectiveness of DES as compared to BMS in patients undergoing pPCI for STEMI. Follow-up data were collected for 3-6 years after the procedure. ST was defined as definite or probable, based on the ARC definition. The study population consists of 6,274 STEMI patients undergoing primary angioplasty with BMS or DES. At 1201 ± 440 days, ST occurred in 267 patients (4.25%). Most of the events were acute or subacute (within 30 days) and very late (> 1 years), with different distribution between DES vs BMS. Patients with ST were more often diabetic (21.7% vs 15.1%, p=0.005), more frequently had post-procedural TIMI 0-2 flow (14.0% vs 9.3%, p = 0.01), and were less often treated with dual antiplatelet therapy at one year follow-up. Diabetes (p = 0.036), post-procedural TIMI 0-2 Flow (p = 0.013) and ischaemia time > 6 hours (p = 0.03) were independent predictors of ST. Post-procedural TIMI 0-2 flow (p = 0.001) and ischaemia time > 6 hours (p < 0.001) were independent predictors of early ST, ischaemia time > 6 hours (p = 0.05) was independent predictor of late ST, whereas diabetes (p = 0.022) and use of DES (p = 0.002) were independent predictors of very late ST. ST was associated with a significantly higher mortality (23.6% vs 6%, p < 0.001). The greatest impact on mortality was observed with subacute (40.4%) and late (20.9%) ST, as compared to acute (12.5%) and very late (9.1%) ST. ST was an independent predictor of mortality (HR [95%CI] = 3.73 [2.75-5.07], p < 0.001). In conclusion, ST occurs relatively frequently also beyond the first year for up to six years after pPCI in STEMI, with higher late occurrence rates among patients treated with first generation DES. ST after pPCI is a powerful predictor of mortality, especially subacute ST.

Quantitative angiography after directional coronary atherectomy

OBJECTIVE--To assess by quantitative analysis the immediate angiographic results of directional coronary atherectomy. To compare the effects of successful atherectomy with those of successful balloon dilatation in a series of patients with matched lesions. DESIGN--Case series. SETTING--Tertiary referral centre. PATIENTS--62 patients in whom directional coronary atherectomy was attempted between 7 September 1989 and 31 December 1990. INTERVENTIONS--Directional coronary atherectomy. MAIN OUTCOME MEASURES--Increase in minimal luminal diameter of coronary artery segment. RESULTS--Angiographic success on the basis of intention to treat was obtained in 54 patients (87%). In four patients the lesion could not be crossed by the atherectomy device; all four had an uneventful conventional balloon angioplasty. Four of the 58 patients who underwent atherectomy were subsequently referred for coronary bypass surgery because of failure or complications; three of them sustained a transmural infarction. In the successful cases, coronary atherectomy resulted in an increase in the minimal luminal diameter from 1.1 mm to 2.5 mm with a concomitant decrease of the diameter stenosis from 62% to 22%. In the subset of 37 patients in which the changes induced were compared with conventional balloon angioplasty atherectomy increased the minimal luminal diameter more than balloon angioplasty (1.6 v 0.8 mm; p less than 0.0001). Conventional histology showed media or adventitia in 26% of the atherectomy specimens. In hospital complications occurred in six patients who had undergone a successful procedure: two transmural infarctions, two subendocardial infarctions, one transient ischaemia attack, and one death due to delayed rupture of the atherectomised vessel. All patients were clinically evaluated at one and six months. One patient had persisting angina (New York Heart Association class II), one patient sustained a myocardial infarction, one patient underwent a percutaneous transluminal coronary angioplasty for early restenosis, and one patient underwent coronary bypass surgery because of a coronary aneurysm formation. At six months 80% (36/47) of the patients were symptom free. CONCLUSIONS--Coronary atherectomy achieved a better immediate angiographic result than balloon angioplasty; however, in view of the complication rate in this preliminary series, which may be related to a learning curve, a randomised study is needed to show whether this procedure is as safe as a conventional balloon angioplasty.